We report on a case of severe cutaneous reaction to darunavir/r and a successful desensitization protocol. The patient was a 41-year-old female, known to be HIV infected for 18 years and who had received several drug regiments in the past. As a consequence, her virus had triple-class mutations but was susceptible to darunavir/r. Her CD4 was 200 cells/mm 3 and HIV viral load 56,000 copies/ mL. Eight days after initiation of darunavir/r the patient developed a severe pruritic vesicular extended cutaneous allergic reaction which required cessation of all drugs. Due to the severity of the allergic reaction no rechallenge was done. After the patient's recovery, the virus was found to be susceptible only to maraviroc, raltegravir, and darunavir/r. Since darunavir/r was an essential component in treating this triple-class mutated virus, a desensitization protocol was applied successfully. Six months after desensitization, the patient is asymptomatic, compliant, and her HIV viral load remains at <20 copies/mL.
Keywords antiretroviral therapy, hypersensitivity reaction, darunavirAntiretroviral therapy (ART) in HIV-infected individuals has changed the course of the disease from a lethal to a chronic, manageable condition. Antiretroviral therapy has improved over the years, with more potent and less toxic drugs. Patients who were infected for several years and were treated with old generation ART developed a series of adverse reactions such as neuropathy, lipodystrophy, anemia, cytopenia, central nervous system involvement, and triple-class ART resistance, in many cases due to noncompliance.Darunavir, a protease inhibitor (PI) with high genetic barrier, is highly effective in patients who developed multidrug-resistant HIV, including cases resistant to older PIs.
1Darunavir contains a sulfonamide moiety and should be used with caution in patients with a known sulfonamide allergy.
2One of the serious adverse events seen in patients undergoing ART is drug hypersensitivity reaction. Such an event may be a serious and sometimes even a lifethreatening condition limiting the number of drugs available for the future management of the HIV-positive patient. Several antiretroviral drugs have been described to cause skin reactions.3-7 Amprenavir (APV) is a PI that most frequently produces adverse cutaneous reactions (in up to 28% of patients),8 but mounting information is also accumulating concerning darunavir. Of note, information on darunavir is mostly from clinical trials due to the limited time that elapsed since its approval.In a phase III clinical trial that randomized 604 patients treated with darunavir/ritonavir (darunavir/r) or lopinavir/ritonavir (LPV/r) plus an optimized background therapy, 16% of the patients who received darunavir/r developed a rash compared to only 7% in the other arm who received LPV/r. Two of the patients who received darunavir/r had a serious rashrelated event requiring treatment cessation, whereas patients who received LPV/r did not develop any serious skin events.
9Another large, open-label ...